Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Controlled Substances Quotas
Document Number: 2018-15141
Type: Rule
Date: 2018-07-16
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is publishing this final rule to strengthen the process for setting controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2018-15139
Type: Notice
Date: 2018-07-16
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2018-15138
Type: Notice
Date: 2018-07-16
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA Into Schedule I
Document Number: 2018-14718
Type: Rule
Date: 2018-07-10
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoids, Naphthalen-1-yl 1-(5-fluoropentyl)-1H- indole-3-carboxylate (trivial name: NM2201; CBL2201); N-(1-amino-3- methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carb oxamide (trivial name: 5F-AB-PINACA); 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)- 1H-indazole-3-carboxamide (trivial name: 4-CN-CUMYL-BUTINACA; 4-cyano- CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78); methyl 2- (1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutano ate (trivial names: MMB-CHMICA, AMB-CHMICA); and 1-(5-fluoropentyl)-N-(2- phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA), and their optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of these synthetic cannabinoids in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB- CHMICA and 5F-CUMYL-P7AICA.
Importer of Controlled Substances Application: S & B Pharma, Inc.
Document Number: 2018-14396
Type: Notice
Date: 2018-07-05
Agency: Drug Enforcement Administration, Department of Justice
Ljudmil Kljusev, M.D.; Decision and Order
Document Number: 2018-14161
Type: Notice
Date: 2018-07-02
Agency: Drug Enforcement Administration, Department of Justice
Decision and Order: Mohammed Asgar, M.D.
Document Number: 2018-13531
Type: Notice
Date: 2018-06-25
Agency: Drug Enforcement Administration, Department of Justice
Decision and Order: Kevin G. Morgan, RN/APN
Document Number: 2018-13530
Type: Notice
Date: 2018-06-25
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2018-13410
Type: Notice
Date: 2018-06-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
Document Number: 2018-13231
Type: Notice
Date: 2018-06-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2018-13224
Type: Notice
Date: 2018-06-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-13223
Type: Notice
Date: 2018-06-20
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2018-13221
Type: Notice
Date: 2018-06-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-12884
Type: Notice
Date: 2018-06-15
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Gazelle A. Craig, D.O.; Decision and Order
Document Number: 2018-12686
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.
Document Number: 2018-12685
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2018-12684
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2018-12683
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Bellwyck Clinical Services
Document Number: 2018-12682
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Restek Corporation
Document Number: 2018-12680
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-12670
Type: Notice
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Schedules of Controlled Substances: Temporary Placement of N-Ethylpentylone in Schedule I
Document Number: 2018-12669
Type: Proposed Rule
Date: 2018-06-13
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is publishing this notice of intent to issue an order temporarily scheduling N-1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1- pentanone (N-ethylpentylone, ephylone) in schedule I. This action is based on a finding by the Acting Administrator that the placement of N- ethylpentylone in schedule I is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the Controlled Substances Act (CSA) on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of N-ethylpentylone, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to N-ethylpentylone.
Richard Hauser, M.D.; Decision and Order
Document Number: 2018-12138
Type: Notice
Date: 2018-06-06
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA Into Schedule I
Document Number: 2018-11531
Type: Proposed Rule
Date: 2018-05-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoids, Naphthalen-1-yl 1-(5- fluoropentyl)-1H-indole-3-carboxylate (trivial name: NM2201; CBL2201); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-in dazole-3- carboxamide (trivial name: 5F-AB-PINACA); 1-(4-cyanobutyl)-N-(2- phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial name: 4-CN-CUMYL- BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78); methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3- methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA); and 1-(5- fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridi ne-3- carboxamide (trivial name: 5F-CUMYL-P7AICA), in schedule I. This action is based on a finding by the Acting Administrator that the placement of these synthetic cannabinoids in schedule I of the Controlled Substances Act (CSA) is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic cannabinoids, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.
Jopindar P. Harika, M.D.; Order
Document Number: 2018-11433
Type: Notice
Date: 2018-05-29
Agency: Drug Enforcement Administration, Department of Justice
Health Fit Pharmacy; Decision and Order
Document Number: 2018-11268
Type: Notice
Date: 2018-05-25
Agency: Drug Enforcement Administration, Department of Justice
Donald Kenneth Shreves, D.V.M.; Dismissal of Proceeding
Document Number: 2018-10305
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-10304
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2018-10303
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Rhodes Technologies
Document Number: 2018-10302
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2018-10301
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Xcelience
Document Number: 2018-10300
Type: Notice
Date: 2018-05-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of beta-Hydroxythiofentanyl in Schedule I of the Controlled Substances Act
Document Number: 2018-10009
Type: Rule
Date: 2018-05-10
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of beta-hydroxythiofentanyl (N-[1-[2- hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropio namide) also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N- phenylpropanamide including its isomers, esters, ethers, salts and salts of isomers, esters and ethers. The schedule I status of beta- hydroxythiofentanyl currently is in effect through May 12, 2018. This temporary order will extend the temporary scheduling of beta- hydroxythiofentanyl for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of beta-Hydroxythiofentanyl Into Schedule I
Document Number: 2018-10008
Type: Proposed Rule
Date: 2018-05-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing beta- hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin- 4-yl]-N-phenylpropionamide) also known as N-[1-[2-hydroxy-2-(2- thienyl)ethyl]4-piperidinyl]N-phenyl-propanamide including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle beta-hydroxythiofentanyl.
William R. Montiel, M.D.; Decision and Order
Document Number: 2018-09738
Type: Notice
Date: 2018-05-08
Agency: Drug Enforcement Administration, Department of Justice
Garrett Howard Smith, M.D.; Decision and Order
Document Number: 2018-09020
Type: Notice
Date: 2018-04-30
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2018-08348
Type: Notice
Date: 2018-04-23
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I
Document Number: 2018-08280
Type: Rule
Date: 2018-04-20
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Administrator of the Drug Enforcement Administration maintains the placement of the substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylbutanamide) and U-47700 (3,4-dichloro-N-[2- (dimethylamino)cyclohexyl]-N-methylbenzamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, butyryl fentanyl and U-47700.
Controlled Substances Quotas
Document Number: 2018-08111
Type: Proposed Rule
Date: 2018-04-19
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is publishing this proposed rule to strengthen controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.
Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc.
Document Number: 2018-07978
Type: Notice
Date: 2018-04-17
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-07455
Type: Notice
Date: 2018-04-11
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances.
Witold Marek Zajewski, M.D.; Decision and Order
Document Number: 2018-07454
Type: Notice
Date: 2018-04-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-07444
Type: Notice
Date: 2018-04-11
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Importer of Controlled Substances Application: Lipomed
Document Number: 2018-07442
Type: Notice
Date: 2018-04-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2018-07441
Type: Notice
Date: 2018-04-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States
Document Number: 2018-07167
Type: Notice
Date: 2018-04-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2018-07165
Type: Notice
Date: 2018-04-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Document Number: 2018-06872
Type: Notice
Date: 2018-04-04
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories Inc.
Document Number: 2018-06871
Type: Notice
Date: 2018-04-04
Agency: Drug Enforcement Administration, Department of Justice
Mehdi Nikparvarfard, M.D.; Decision and Order
Document Number: 2018-06870
Type: Notice
Date: 2018-04-04
Agency: Drug Enforcement Administration, Department of Justice